# K050928: Dade Thrombin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jun 29, 2005 after 76 days
- Product code: KQJ (System, Fibrinogen Determination)
- Device class: 2
- Regulation: 21 CFR 864.7340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Dade® Fibrinogen Determination Reagents kit (Pre-1976): named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K860038: Dade® Thrombin Reagent. The summary prints BK860038, a CBER number, which our reading took as K860038, which is not in FDA’s 510(k) list. Kept off the family tree. Summary page 1.

## Indications for use
For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies.

Source page: https://510kreport.com/device/K050928
Methodology: https://510kreport.com/methodology